HiResolution Bionic Ear System
FDA premarket approval P960058/S166 · decided 2024-12-18
Approval details
- PMA number
- P960058
- Supplement
- S166
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2024-11-18
- Decision date
- 2024-12-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval for relocation of a supplier manufacturing facility and manufacturing changes to a surgical tool used with HiRes Ultra CI HiFocus MS Electrode, HiRes Ultra 3D CI HiFocus MS Electrode and HiFocus Mid-Scala Electrode Insertion Tool Kit
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